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PixCell Medical Technologies Ltd.

Israel · Yokneam Ilit · www.pixcell-medical.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN IL-MF-000026612

This company has registrations in European Union, United States, United Kingdom, Canada, Australia — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
5UDI-DI device records
IVD A 2IVD B 3
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 7 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
4registered device records
IVD general 4
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IVD Class 1 1IVD Class 2 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union5 raw hits, 0 excluded, 5 confirmed
United States7 registration records, 3 510(k), 0 PMA
United Kingdom4 confirmed, 0 excluded
Manufacturer names merged into this page: PIXCELL MEDICAL INC. · PIXCELL MEDICAL · PIXCELL MEDICAL TECHNOLOGIES LTD

Regulatory identity

EU manufacturer SRN
IL-MF-000026612
EU authorised representative
AR Experts B.V.
UK responsible person
UKCA Experts Ltd

Company information

Country
Israel
City
Yokneam Ilit
Website
www.pixcell-medical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsPoint-of-care & near-patient testing

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12018 · K180020
12023 · K222148
12024 · K240636

FDA listed device types

Counter, Differential Cell 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1

Registration details (sample)

MarketIdentifierNameClass / date
EU07290016991109HemoScreenIVD B
EU07290016991000HemoScreenIVD B
EU07290016991017HemoScreen CBC CartridgeIVD B
EU27290016991073HemoScreen CBC SamplerIVD A
UK58146HemoScreen Blood Dispensing CupIVD general
UK57892HemoScreen CBC SamplerIVD general
UK55854HemoScreen CBC CartridgeIVD general
USK240636HemoScreen Hematology Analyzer2024-05-02
USK222148HemoScreen Hematology Analyzer2023-08-16
USK180020HemoScreen Hematology Analyzer2018-10-29

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